Cleared Traditional

K852540 - ULTRASONIC TOOTH SCALER MODEL DSCIOP

K852540 is an FDA 510(k) clearance for ULTRASONIC TOOTH SCALER MODEL DSCIOP, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K852540 · Parkell, Inc. · Dental device
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Jul 1985
Decision
17d
Days
Class 2
Risk

K852540 is an FDA 510(k) clearance for the ULTRASONIC TOOTH SCALER MODEL DSCIOP. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K852540

510(k) Number K852540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date July 01, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 128d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 194
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K852540.
GENTEEL
K863676 · Luben Dental Co., Inc. · Oct 1986
HARMO SONIC
K853841 · U.S. Shizai Corp. · Feb 1986
SATALEC PIEZOTEC
K852525 · Spelna, Inc. · Jan 1986
OSADA ENAC
K844250 · Osada Electric Co., Ltd. · Jan 1985
CAVI-MED
K842581 · Cooper Lasersonics, Inc. · Aug 1984
SATELEC SUPRASSON PIEZOMATIC P2
K832664 · Spelna, Inc. · Mar 1984
K852540 · ULTRASONIC TOOTH SCALER MODEL DSCIOP
Download PDF Parkell, Inc.